FDA Approves KEYTRUDA® (pembrolizumab) and KEYTRUDA QLEX™ (pembrolizumab and berahyaluronidase alfa-pmph), Each With WELIREG® (belzutifan), for Adjuvant Treatment of Certain Patients With Clear Cell Renal Cell Carcinoma (ccRCC)
Marks the first approved combinations of a PD-1 and HIF-2α inhibitor
Approvals based on Phase 3 LITESPARK-022 trial that showed KEYTRUDA in combination with WELIREG reduced the risk of disease recurrence, metastasis or death by 28% compared to KEYTRUDA plus placebo
Represents the first and only global Phase 3 study to have demonstrated an improvement in disease-free survival over KEYTRUDA monotherapy in adjuvant ccRCC
Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today announced the U.S. Food and Drug Administration (FDA) approved KEYTRUDA® (pembrolizumab) and KEYTRUDA QLEXTM (pembrolizumab and berahyaluronidase alfa-pmph), Merck’s anti-PD-1 therapies, each in combination with WELIREG® (belzutifan), Merck’s first-in-class, oral hypoxia-inducible factor-2 alpha (HIF-2α) inhibitor, for the adjuvant treatment of adult patients with renal cell carcinoma with a clear cell component (ccRCC) at intermediate-high or high risk of recurrence following nephrectomy, or following nephrectomy and resection of metastatic lesions. These approvals represent the first approval for WELIREG in earlier-stage ccRCC and the first approvals for PD-1 and HIF-2α inhibitor combination regimens.
